MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	EVD35-08-040-120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Physician attempted to use an everflex entrust self-expanding stent during treatment of the patients proximal peroneal artery.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.Embolic protection was not used.The device was not passed through a previously deployed stent.No resistance was encountered when advancing the device.Tip detachment during use in the patient was reported.It was reported a portion of the plastic on the distal end of the stent deployment system broke off and intervention was required.The stent was deployed in the target lesion.The catheter handle was not deliberately cracked to aid stent deployment.The tip was left in the patient.Procedure was aborted.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20408487
• Report Number: 2183870-2024-00346
• Device Sequence Number: 3378937
• Product Code: NIP
• UDI-Device Identifier: 00821684051504
• UDI-Public: 00821684051504
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: EVD35-08-040-120
• Device Lot Number: B677577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/09/2024
• Date Device Manufactured: 01/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown